Validation of Fitbit Measurements in Hospitalized General Medicine Patients

NCT07229833 | Active Not Recruiting

• 1 other identifier: 24-5399
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients admitted to the General Internal Medicine ward are sick and in need of monitoring that cannot be provided at home or treatments best administered in hospital. Standard care currently includes vital signs measurements and in some cases ECG. Wearable devices that continuous monitor patients could provided added information to improve the care of inpatients. This could include more monitoring and catching deterioration before it happens. Wearables have been shown to be largely accurate for monitoring heart rate, however it is still necessary to determine if they can reliably measure sleep, activity, and other health metrics. For this, study investigators are evaluating the validity of FitBit Sense 2 (or other FitBit devices) for measurement of sleep, activity, heart rate, respiratory rate, and oxygen saturation.

Conditions

GIM Diagnosis; Medicine; Admission to GIM

Keywords

wearable; sleep; heart rate

Outcome Measures

Primary Outcomes (9)

• Fitbit Sense 2 vs. StepWatch for activity (step count)

  Comparisons of step counts between Fitbit and Modus StepWatch

  Collected over 24 hours in 1 min bins

• Fitbit Sense 2 vs. Nox T3 for heart rate (bpm)

  Comparisons of HR between Fitbit and Nox pulse oximeter

  Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins

• Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute)

  Comparisons of RR between Fitbit and Nox RIP (respiratory inductive plethysmograph)

  Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins.

• Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %)

  Comparisons of SpO2 between Fitbit and Nox T3

  Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins.

• Fitbit Sense 2 vs. Nox T3 for total sleep time (min)

  Comparisons of sleep TST between Fitbit and Nox T3

  Fitbit and Nox T3 collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%)

  Comparisons of SE between Fitbit and Nox T3

  Fitbit and Nox T3 collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min)

  Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3

  Fitbit and Nox T3 collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min)

  Comparisons of WASO between Fitbit and Nox T3

  Fitbit and Nox T3 collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time

  Comparisons of sleep onset time and wake time between Fitbit and Nox T3

  Fitbit and Nox T3 collected during nighttime sleep (1 night)

Secondary Outcomes (7)

• Fitbit Sense 2 vs. Sleep Diary for total sleep time (min)

  Collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%)

  Collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule

  Collected during nighttime sleep (1 night)

• Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min)

  Collected during nighttime sleep (1 night)

• Subgroup analysis based on gender

  Collected at study baseline

Study Arms (1)

General internal medicine patients admitted to General Medicine Wards

Intervention: Fitbit Sense 2 (Fitbit, San Francisco, CA, USA) Gold standard devices: To compare measures, patients will be asked to wear the following for 24 hours: * Sleep study device - Nox T3 chest band with oximeter. Participants will be asked to wear this for 24 hours. The Nox T3 monitors chest movement and determines sleep stages. It is paired with a Nonin oximeter. This provides continuous oxygen saturation monitoring as well as heart rate and respiratory rate. * Step counter - An ankle-worn Stepwatch Activity Monitor which has been validated in hospital patients who move slowly.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be General Internal Medicine inpatients on the GIM wards. Patients who can provide informed consent will be approached for enrollment. Exclusion criteria are patients who are purely palliative and therefore in which vital sign measurement would be inappropriate.

You may qualify if:

• General internal medicine patients admitted to General Medicine Wards.
• Able to consent.
• years of age or older

You may not qualify if:

• Patients who are purely palliative "comfort measures only" where measuring vital signs would not be appropriate and will be excluded.
• To reduce the potential risk of transmitting nosocomial infections, patients under contact precautions for methicillin resistant Staphylococcus aureus (MRSA) and Clostridium difficile infections will also be excluded.
• This study will also exclude patients at risk of vascular compromise of the arm or leg on which the wearable device was to be placed, such as patients with deep venous thrombosis, dialysis fistulas, and severe upper extremity trauma.
• Expected discharge less than 24 hours

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: November 17, 2025
• Study Start: June 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)